(Job level to be determined based upon qualifications)
This function is responsible for supporting the daily manufacturing and facility operations. Functions include validation documentation approval, aseptic gowning training, batch record review, and training program support.
The position will also be required to provide general Quality Assurance support and application of regulatory requirement knowledge in solving problems and making recommendations.
• Consultative support for manufacturing on the floor to ensure adherence to procedures and industry practices
• Interaction with plant personnel to ensure cGMP compliance and continuous improvement.
• Approve validation documentation based on adherence to industry standards and regulations.
• Maintenance of documentation in accordance with GMP including timely recording of information.
• Approval of written procedures and other documents
• Batch record review
• Follow-up, tracking and escalation as appropriate of preventive and corrective actions associated with deviations, lab investigations and Environmental Excursions
• Active participation in project activities as required
• Knowledge of Regulations pertinent to Aseptic Processing
• Comprehensive knowledge of validation principles
• Experience with delivery of training
• Commitment to consistently meeting high standard of work
• Strong attention to detail
• Strong interpersonal skills when dealing with all organizational levels.
• Commitment to continuous improvement in all areas.
• Able to mentor other employees
• Can work independently without supervision
• Ability to cope with a rapidly changing work environment.
• Ability to work safely; seek out and encourage safe practices.
• Requires a Bachelor’s degree in a scientific discipline or equivalent.
• Minimum of 2 years’ experience in a Quality Assurance role in the pharmaceutical industry.
Alkermes, Inc. - 20 months ago